PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy (PIR-008/K)
This study is ongoing, but not recruiting participants.
Sponsor:
Desitin Arzneimittel GmbH
Information provided by (Responsible Party):
Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT01519856
First received: March 12, 2010
Last updated: February 28, 2013
Last verified: January 2012
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Purpose
Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from the literature that the antagonistic properties of piribedil are correlated with an improvement of cognitive function and vigilance parameters in parkinson's disease. The aim of the present non-interventional study is to investigate the safety and efficacy of piribedil during long-term therapy of patients with M. Parkinson under consideration of cognitive functions and quality of life.
| Condition | Intervention |
|---|---|
|
Parkinson's Disease |
Drug: piribedil (Clarium) |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Efficacy and Safety of Long-term Therapy With Piribedil (CLARIUM) in Patients With M. Parkinson Under Consideration of Quality of Life Parameters and Cognitive Function |
Resource links provided by NLM:
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Loratadine
U.S. FDA Resources
Further study details as provided by Desitin Arzneimittel GmbH:
Primary Outcome Measures:
- Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Influence on quality of life [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- Quality of life parameters [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 908 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| tablet |
Drug: piribedil (Clarium)
oral tablets, 50 mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
male and female patients with Morbus Parkinson
Criteria
Inclusion Criteria:
- newly diagnosed or advanced idiopathic Parkinson's disease
- male and female patients over 18 years of age
- indication for treatment with piribedil according to Summary of Product Characteristics (SmPC)
Exclusion Criteria:
- in line with piribedil SmPC
- in particular hypersensitivity to piribedil or to any of the excipients and pregnancy and lactation as stated in the SmPC
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Desitin Arzneimittel GmbH |
| ClinicalTrials.gov Identifier: | NCT01519856 History of Changes |
| Other Study ID Numbers: | PIR-008/K |
| Study First Received: | March 12, 2010 |
| Last Updated: | February 28, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Desitin Arzneimittel GmbH:
|
open non-intervention observational |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Piribedil Loratadine Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipruritics Dermatologic Agents Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents |
ClinicalTrials.gov processed this record on May 21, 2013